CYTOQUANT VIRAL TRANSPORT MEDIUM

• K Number: K961756
• Device Name: CYTOQUANT VIRAL TRANSPORT MEDIUM
• Manufacturer: PROTEINS INTL., INC.
• Date Cleared: 1996-05-17 ( 11 days)
• Product Code: JSN
• Regulation Number: 866.2390

Intended Use

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Device Description

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.

Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a specimen collection and transport device, which is a passive container and does not involve data processing or analysis typically associated with AI/ML. There are no mentions of AI, ML, image processing, or data analysis in the provided text.

Therapeutic

No
The device is described as a specimen collection and transport device that preserves microorganisms for diagnostic purposes, not for treating any disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states: "The device aids in the diagnosis of disease caused by pathogenic microorganisms." This explicitly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "specimen collecting chamber," which is a physical hardware component.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states that the device "aids in the diagnosis of disease caused by pathogenic microorganisms." This is a key characteristic of an IVD, as it is used to provide information for diagnostic purposes.
• Function: The device is designed to collect and transport microbiological specimens while preserving the viability of microorganisms. This is a crucial step in the process of performing in vitro diagnostic tests on these specimens.
• Performance Studies: The document mentions performance studies related to maintaining virus viability, which is directly relevant to the diagnostic function of the collected specimen.

While the device itself doesn't perform the diagnostic test, it is an essential component in the process of obtaining a specimen that will be used for an in vitro diagnostic test. Therefore, it falls under the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Product codes

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Device Description

The CytoQuant™ Viral Transport Medium is a microbiological specimen collection and transport device. It is specifically described as "CytoQuant™ Viral Transport Medium (Tryptose Phosphate Broth)".

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

Laboratory personnel accustomed to BioSafety Level II precautions. The document details specific precautions for handling the medium in a laboratory setting.

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time. Complete study results for each lot are available on request.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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Regulation Number and Section

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).

Summary

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MAY 17 1996

SAFETY & EFFECTIVENESS SUMMARY CytoQuant™ VIRAL TRANSPORT MEDIUM

A. SAFETY

According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms. These devices are classified as (lass I (general controls).

Proteins International recommends that the Cyto()uant™ Viral Transport Medium be handled at BioSafety Level II with the following precautions taken:

• 1 . Access to the laboratory is limited .
• 2. All work surfaces are Decontaminated before and after each procedure.
• 3. Use of automatic pipetting devices is mandatory for all procedures - mouth pipetting is prohibited.
• 4. Eating, drinking, smoking, and applying cosmetics is not permitted in the laboratory, nor is food stored in the lab areas.
• ട. Laboratory coats are worn in the laboratory and removed before leaving.
• 6. Hand washing is required before and after handling transport medium.
• 7. A class II laminar flow biological safety cabinet is used for all manipulations which may create aerosols whether or not the procedure requires sterility.
• 8. Contaminated materials are placed in leakproof, autoclavable discard pans filled with distilled water.
  • These pans are closed before removal from the cabinet.
• 9. Larger plasticware, such as a tissue culture flask, which does not fit in a discard pan, is to be closed and placed in an autoclave bag.
• 10. All contaminated materials are aut oclaved before disposal.
• 11. Contaminated liquid media collected by vacuum aspiration is inactivated by the addition of bleach to make a 1:15 bleach to media solution, and then discarded.
• 12. Disposable latex gloves are worn when skin contact with infectious materials is unavoidable or at the discretion of the operator.

Proteins International also has available on request a copy of the MSDS for any antibiotic or antimycotic agent used in the formulation of the medium.

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B. EFFECTIVENESS

The CytoQuant™ Viral Transport Medium (Tryptose Phosphate Broth) is widely recognized as an effective medium for transport of viruses. 1, 2, 3

Additionally, Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time. Complete study results for each lot are available on request, as well as suggested OC/OA procedures for those users wishing to perform their own quality testing.

References:

1. Johnson, F. B. 1990. Transport of Viral Specimens. Clin. Micobiol. Rev. 3: 120-131

2. Lennette, D. A. 1985. Collection and preparation of specimens for virological examination, p 687-693. In E. H. Lennette, A. Balows, W. J. Housler, Jr. and H. J. Shadomy (Eds), Manual of clinical microbiology, 4th ed. American Society for Microbiology, Washington, D. C.

3. Madeley, C. F., D. A. Lennette and P Halonen. 1988. Specimen collection and transport, p.7-11. IN E. H. Lennettee, P. Halonen and F. A. Murphy (Eds), Laboratory diagnosis of infectious diseases, principles and practice, vol 2. Springer Verlag, New York.